Housing arrangements for infusion pumps

ABSTRACT

An infusion pump, including a housing, a user interface, a motor and a set of drive components, and a controller. The housing enables selective stacked attachment with other infusion pumps. The housing includes a top portion with a handle integrated into an outer surface that partially defines a generally U-shaped retaining feature. The housing also includes a bottom portion with a generally U-shaped projection that is contoured to selectively mate with the retaining feature of another infusion pump. The user interface provides a front side to the housing that receives commands regarding infusion pump operation. The motor and set of drive components are at least partially located within the housing and mechanically direct infusion of infusate. The controller is located within the housing and that controls operation of the motor and the set of drive components.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 16/627,949,filed Dec. 31, 2019, which is a National Stage entry of PCT ApplicationNo. PCT/US2018/042907 filed Jul. 19, 2018, which claims the benefit ofProvisional Application No. 62/534,407, filed on Jul. 19, 2017, thedisclosures of which are incorporated by reference herein.

TECHNICAL FIELD

Embodiments relate generally to medical devices and, more particularly,to housing arrangements for infusion pumps in the form of syringe pumpsand large volume pumps (LVPs).

BACKGROUND

In the medical arts, infusion pumps have been useful for managing thedelivery and dispensation of a prescribed amount or dose of a drug,fluid, fluid-like substance, or medicament (hereinafter, collectively,an “infusate”) to patients. Infusion pumps can provide some significantadvantages over manual infusion techniques, by accurately delivering anddispensing infusates over an extended period of time.

Infusion pumps are particularly useful for treating diseases anddisorders that require regular pharmacological intervention, includingcancer, diabetes, and vascular, neurological, and metabolic disorders.They also enhance the ability of healthcare providers to deliveranesthesia and manage pain. Infusion pumps are used in various settings,including hospitals, nursing homes, and other short-term and long-termmedical facilities, as well as in residential care settings. Infusionpumps can include various constructions, modes of operation, and types.

Generally, infusion pumps can include a variety of types of pumps. Insome cases, these infusion pumps include syringe pumps and LVPs.Depending upon their specific designs and intended uses, infusion pumpscan be used to administer infusates through various delivery methods androutes, including intravenously, intraperitoneally, enterally,intra-arterially, subcutaneously, neuraxially, and specifically into anintraoperative site, epidural space, and subarachnoid space.

While various syringe pumps and LVPs have been used in medicalenvironments for many years, these devices remain rather complex medicaldevices with some limitations to their efficient, effective, and safeuse. Therefore, there is a need for syringe pumps and LVPs which providegreater flexibility and ease of use to operators. Moreover, due to thevital role of infusion pumps in many medical procedures and treatments,syringe pumps and LVPs which provide enhanced safety to patients areneeded as well.

SUMMARY

Embodiments described or otherwise contemplated herein substantiallyprovide the advantages of improving flexibility, ease of use, operation,as well as patient safety, among other advantages.

An embodiment relates to an infusion pump, including a housing, a userinterface, a motor and a set of drive components, and a controller. Thehousing enables selective stacked attachment with other infusion pumps.The housing includes a top portion with a handle integrated into anouter surface that partially defines a generally U-shaped retainingfeature. The housing also includes a bottom portion with a generallyU-shaped projection contoured to selectively mate with a retainingfeature of another infusion pump. The user interface provides a frontside to the housing that receives commands regarding infusion pumpoperation. The motor and set of drive components are at least partiallylocated within the housing and mechanically direct infusion of aninfusate. The controller is located within the housing and controlsoperation of the motor and the set of drive components.

An embodiment relates to a syringe pump, including a syringe receptacle,a syringe plunger driver assembly, and a housing. The syringe receptacleis configured to receive a syringe of an infusate. The syringe plungerdriver assembly is located adjacent the syringe receptacle and directsthe infusate from the syringe to a patient based on movement and forceagainst a plunger of the syringe. The housing is coupled with thesyringe receptacle and has a front side that includes a graphical userinterface (GUI) display for controlling the syringe pump. The syringereceptacle is located on the front side of the housing verticallyadjacent the GUI display in non-overlapping and non-visually obscuringalignment. The housing is configured such that both the syringe in thesyringe receptacle and the entire GUI display are substantially visibleon the front side of the housing.

An embodiment includes an infusion pump assembly. The infusion pumpassembly includes a first infusion pump having a housing and a userinterface with a display screen. The infusion pump assembly also has a“headless” infusion pump having no display screen. The headless infusionpump is releasably coupled to the housing of the first infusion pump bytongue-and-groove attachment.

An embodiment relates to a “field replaceable unit” for infusion pumps.The field replaceable unit includes a rear housing for an infusion pump.The rear housing includes a top portion and a bottom portion. The topportion has an integrally formed handle structure and a set of grooves.The bottom portion has a projection for releasable coupling with groovesin another rear housing. The rear housing includes a power receptacleand an Ethernet port. The rear housing interchangeably couples with aset of medication delivery components, a control system, and a displayof either a LVP or a syringe pump.

The above summary is not intended to describe each illustratedembodiment or every implementation of the subject matter hereof. Thefigures and the detailed description that follow more particularlyexemplify various embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

Subject matter hereof may be more completely understood in considerationof the following detailed description of various embodiments inconnection with the accompanying figures, in which:

FIG. 1 is front perspective view of a syringe pump, according to anembodiment.

FIG. 2 is a rear perspective view of a syringe pump, according to anembodiment.

FIG. 3 is a front view of a syringe pump, according to an embodiment.

FIG. 4 is a rear view of a syringe pump, accordingly to an embodiment.

FIG. 5 is a top view of a syringe pump, according to an embodiment.

FIG. 6 is a bottom view of a syringe pump, according to an embodiment.

FIG. 7 is a general system diagram of a syringe pump, according to anembodiment.

FIG. 8 is front perspective view of a LVP, according to an embodiment.

FIG. 9 is a rear perspective view of a LVP, according to an embodiment.

FIG. 10 is a front view of a LVP, according to an embodiment.

FIG. 11 is a rear view of a LVP, accordingly to an embodiment.

FIG. 12 is a top view of a LVP, according to an embodiment.

FIG. 13 is a bottom view of a LVP, according to an embodiment.

FIG. 14 is a general system diagram of a LVP, according to anembodiment.

FIG. 15 is a perspective view of an example of an FRU comprising a rearhousing portion for a syringe pump or LVP, according to an embodiment.

FIG. 16A is a perspective view of a racking arrangement of infusionpumps, according to an embodiment.

FIG. 16B is a perspective view of a stacking arrangement of infusionpumps, according to an embodiment.

FIG. 17 is a perspective view of an infusion pump arrangement having anexternal backup battery pack, according to an embodiment.

FIG. 18 is a perspective view of a stacking arrangement of a LVP withother “headless” LVPs, according to an embodiment.

While various embodiments are amenable to various modifications andalternative forms, specifics thereof have been shown by way of examplein the drawings and will be described in detail. It should beunderstood, however, that the intention is not to limit the claimedsubject matter to particular embodiments described. On the contrary, theintention is to cover all modifications, equivalents, and alternativesfalling within the spirit and scope of the subject matter as defined bythe claims.

DETAILED DESCRIPTION OF THE DRAWINGS

In FIGS. 1-7 , various views of an infusion pump in the form of asyringe pump 100 are shown. Similarly, in FIGS. 8-14 various views of aninfusion pump in the form of a LVP 200 are shown. Both syringe pump 100and LVP 200 make use of field replaceable unit (FRU) designs including aplurality of individual FRUs that enable pump components to be readilyupgraded or replaced. Some FRUs are common to both syringe pump 100 andLVP 200. “Syringe pumps” generally include pumps for acting on apre-filled infusate syringe that is mechanically driven undermicroprocessor control to deliver a prescribed amount or dose of theinfusate at a controlled rate to a patient through an infusion linefluidly connected to the syringe. Syringe pumps typically include amotor that rotates a leadscrew or adjustment mechanism, for example. Theleadscrew or adjustment mechanism, in turn, activates a syringe plungerdriver of the syringe pump which in turn pushes forwardly against aplunger within a barrel of the syringe. Pushing the plunger forward thenforces a dose of the infusate outwardly from the syringe, into theinfusion line, and to the patient as aforedescribed. As used throughoutthis disclosure, the term “syringe pump” is intended to generallypertain to any medical infusion pump or device which acts on a syringeto controllably force fluid outwardly therefrom.

“LVPs” can take on various forms, but are typically infusion pumpscoupled to one or more reservoirs configured to hold or store arelatively large amount of infusate or infusates, such as a cassette, IVbag, or other self-contained source. As used throughout this disclosure,the term “LVP” is intended to generally pertain to any medical infusionpump or device capable of large volume infusion to a patient.

Syringe Pump

Referring first to FIGS. 1-6 , syringe pump 100 generally includes auser interface 110, housing 112, syringe plunger driver assembly 114,and syringe receptacle 116. Various other features of the syringe pump100, including some that are internal or partially or fully obscured bythe housing 112, will be later described with reference to the systemdiagram of FIG. 7 .

As seen in FIG. 1 , user interface 110 generally includes a displayscreen 118 and a keypad 120. Display screen 118 can be a rectangular,color LCD screen, and can be a touchscreen in certain embodiments.Display screen 118 can be any type of GUI display for use in controllingthe syringe pump 100. In some embodiments, the display screen 118 can beconfigured to permit display of four lines of text, up to thirtycharacters long each. Accordingly, this size of display screen 118advantageously enables viewing information such as, for example, drugnames of significant length.

In some embodiments, certain commands or instructions are not controlledby a touchscreen, such as a display screen 118 and, instead, arecontrolled by a keypad 120. Keypad 120 is located adjacent to thedisplay screen 118 and presents a variety of buttons and indicatorlights. In some embodiments, push buttons requiring physical mechanicalactuation are used on the keypad 120 for certain user commands,including: on/off power; audible alarm mute; start infusion, and stopinfusion. Additional or fewer buttons on keypad 120 are contemplated aswell. Physical mechanical actuation buttons, for primary or redundantpurposes, provide increased safety and reliability to operators in caseswhere the touchscreen of a display 118 does not function properly, or isotherwise difficult to manipulate correctly. Having a user interface 110including both a display screen 118 and a keypad 120, accordingly,provides the flexibility of a screen interface as well as the enhancedsafety and reliability of physical control buttons.

The housing 112 generally forms a protective shell surrounding theinternal components of the syringe pump 100. In some embodiments, theuser interface 110 may be considered part of the housing 112. Thehousing 112 can be characterized as generally comprising a front housingassembly 122 and a rear housing assembly 124. Front housing assembly 122generally surrounds the LCD display screen 118, keypad 120 and othercomponents around the user interface 110. The front housing assembly 122includes side panels 126 along the front portion of the syringe pump100. A grouping of small holes can be located on one or both side panels126 of the front housing 122 for audio speakers 128.

As illustrated in, for example, FIG. 4 , rear housing assembly 124generally includes a variety of contoured surfaces and shapes to protectthe internal components of the syringe pump 100. The top portion 130 ofthe rear housing assembly 124 provides features defining a handle 132.The handle 132 is integrally formed into the outer surface of the rearhousing assembly 124 and is partially defined by a central recess 134 inthe top portion 130 of housing 112. The handle 132 provides a convenientstructure for grasping, manipulating, and moving the syringe pump 100.The integrally formed nature of the handle 132 with the rest of thehousing 112 provides advantages in medical settings due to an ability tobe rather easily cleaned. In contrast, a non-integral handle and housingarrangement having a separate hinge or attachment features, couldpresent a much more difficult component or assembly to clean.

As illustrated in, for example, FIG. 5 , handle 132 is further part of agenerally U-shaped retaining feature 136. Generally U-shaped retainingfeature 136 can provide releasable interlocking engagement with otherinfusion pumps or related components. As illustrated in the perspectiveviews of FIGS. 1 and 2 , and particularly the top view of FIG. 5 , thegenerally U-shaped retaining feature 136 can be seen. Generally U-shapedretaining feature 136 includes an upper lip portion 138 that extendsinwardly around the central recess 134 located at the top portion 130 ofthe housing 112. The upper lip portion 138 extends around three sides ofthe recess 134, to form a general “U” shape when viewed from above. Thesection of the upper lip portion 138 in the middle of the general “U”shape partially comprises the handle 132. Beneath an overhang of thissection of the upper lip portion 138 is a more deeply recessed space inwhich a user attempting to lift the syringe pump 100 can place his orher fingers and readily grasp the handle 132 from above.

In addition to the upper lip portion 138, the generally U-shapedretaining feature 136 further includes a set of receiving grooves 140(as partially illustrated in, for example, FIGS. 2 and 4 ) underneaththe upper lip portion 138, adjacent the rear face 142 of the rearhousing assembly 124 at each end of the “U” shape. The receiving grooves140 are slots which progressively narrow in structure and convergeinwardly from the rear face 142 of the rear housing assembly 124.Forward of the receiving grooves 140 is a narrowed section 144 ofhousing, against which an inserted member can abut.

As illustrated in, for example, FIGS. 1 and 4 , a latch 146 having acatch 148 is located on one side of the set of receiving grooves 140.This catch 148 is spring-loaded and able to click into place to hold amember loaded in the receiving grooves 140. Opposite these latch 146 andcatch 148 members, on the side of the upper portion of the housing 112,is a further pump latch button 150. Pump latch button 150 can be pressedto unlock the latch 146 and catch 148 members such that a pump orcomponent that is stacked and engaged to the handle 132 by receivinggrooves 140, can be released and removed.

As shown in FIG. 2 , rear housing assembly 124 also includes adownwardly extending and generally U-shaped projection 152 on a bottomportion 154 of pump 100. The generally U-shaped projection 152 is aprotruding structure that can be placed in grooves (similar to receivinggrooves 140 from other similar or identical pumps or devices). Thegenerally U-shaped projection 152 is located on the bottom portion 154of the rear housing assembly 124. As most clearly seen in the bottomview of the syringe pump 100 in FIG. 6 , the generally U-shapedprojection 152 includes a forward portion 156 and rearward portions 158.

The forward portion 156 of the generally U-shaped projection 152 islocated in the middle of the “U” shape. The forward portion 156 forms atightly curved “U” shape. The forward portion 156 provides a surfacethat can abut up against and mate with a corresponding surface of a pumpor device, similar to that of narrowed section 144 of the generallyU-shaped retaining feature 136 on the top portion 130 of the housing112. The rearward portions 158 of the generally U-shaped projection 152each provide segments of wider separation than the sides of the forwardportion 156. The rearward portions 158 of the generally U-shapedprojection 152 include a flange 160 with an outwardly extending lip 162as illustrated in, for example, FIGS. 2 and 4 . When taken together, theflange 160 and outwardly extending lip 162 provide a feature for slidingengagement. The generally U-shaped projection 152, accordingly, providesa structure that can be releasably slid into and engaged below an upperlip portion 138 and within receiving grooves 140 of the generallyU-shaped retaining feature 136. This type of coupling effectivelyprovides so-called “tongue and groove” retention. Accordingly, thegenerally U-shaped retaining feature 136 and generally U-shapedprojection 152 can enable multiple infusion pumps 100 to be stackedvertically on top of one another in an engaged tongue and groovearrangement when the pumps include those features compatibly.

In FIG. 2 , other features that can be seen on the back, sides, andbottom of the housing 112 include: a battery door cover 164, powerreceptacle 166, Ethernet connector 168, USB port 170, and supportstructures or “mounting feet” 172 (that will be described in furtherdetail). In general, battery door cover 164 provides a plate that can beremoved to access a battery 174 (as depicted schematically in FIG. 7 )located within the housing 112 of syringe pump 100. Battery door cover164 is generally rectangular in shape but includes curved perimeterfeatures to accommodate removable fasteners 176. Due to its ease ofaccess and removal, battery 174 can be characterized as being a separateFRU for purposes of removal and replacement.

With reference again to, for example, FIGS. 2 and 4 , power receptacle166 is located in the back of the rear housing assembly 124 of thesyringe pump 100. Power receptacle 166 may interface directly with apower cord, or alternatively, with a power connector contained on a pumprack. In the case of connection to a power cord, the power receptacle166 provides a mechanical lock and retaining feature that prevents thepower cord from being unintentionally pulled from operative engagementwith the syringe pump 100. This can be useful to prevent power loss inan event of a slightly or unintentionally pulled or bumped power cord.The power receptacle 166 also has a tapered bevel structure which helpsto accommodate interfacing with a power connector on a rack where theuser typically has limited visibility for ensuring alignment.

Male and female connector portions can be keyed or otherwise restrictedor controlled in orientation such that interlocking of the male andfemale components can only be made in a specified orientation. This canbe advantageous in assisting proper alignment of pins, e.g., (+) to (+),and (−) to (−). The power cord connector can be keyed such that itcannot be connected in an improper orientation. In particular, the powercord connector can be a “right angle” connector, in some embodiments,yielding a low profile to decrease possible entanglements.

An Ethernet connector 168 is located on the side of housing 112 (in thisexample, near a back lower portion of the syringe pump 100). Thislocation provides convenient access to other pumps, racks orcommunication devices that utilize Ethernet for data transfer. Ethernetconnector 168 can be “ingress-protection” (or “IPX”) rated and does notrequire a cover. Similarly, USB port 170 is located on a side of housing112 (in this example, near speaker 128). USB port 170 can have a coverand can be a so-called “on-the-go” connector for use with a variety ofperipheral devices and applications.

Also designed to provide the stackable and user friendly design ofsyringe pump 100 are a set of support structures or mounting feet 172.In this example of pump 100, mounting feet 172 include two frontmounting feet 172 a and two rear mounting feet 172 b. Front mountingfeet 172 a are extensions of the sides of housing 112 and rear mountingfeet 172 b are components that act to raise a back side of the housing112. Rear mounting feet 172 b provide clearance to the bottom portion154 of the housing 112, such that the generally U-shaped projection 152can extend downwardly without interfering with or causing disruption tophysical stability of the pump 100. Similarly, in general, the mountingfeet 172 are positioned so that stacked infusion pumps will notinterfere with one another.

Also shown in FIGS. 1-6 , is a syringe receptacle 116 and syringeplunger driver assembly 114. Syringe receptacle 116 includes an elongatecavity extending across the front of the syringe pump 100. Syringereceptacle 116 is located directly below the display screen 118 of theuser interface 110. Location of the syringe receptacle 116 below theuser interface 110 is advantageous in a number of respects. A syringereceptacle location below the user interface 110 aids in preventingleakages, fluid drips, or other unwanted contaminants from interferingwith the display 118, keypad 120 or other potentially damageableelectronic and mechanical features. In this location, the syringereceptacle 116 is somewhat spatially isolated from the remainder of thesyringe pump 100 in the event of damages from syringe loading,unloading, or manipulation.

Syringe receptacle 116 contains a syringe ledge 178 on which a syringecan be operatively positioned. Syringe receptacle 116 effectivelyprovides a cavity in the syringe pump 100 that remains open to the frontof the pump 100 such that a loaded syringe is readily and substantiallyvisible. Since the display screen 118 is located above the syringereceptacle 116, the screen 118 is generally not visually obstructed bypresence of a syringe in pump 100. This non-overlapping and non-visuallyobscuring alignment of the receptacle and the screen simultaneouslyprovides good visibility of both the syringe and display screen 118 inoperation of pump 100.

Syringe receptacle 116 further includes an infusion line retentionpassage 180 (or tube guide) at one end, located opposite the endadjacent the syringe plunger driver assembly 114. The retention passage180 provides a narrow segment in which an infusion line can pass.Specifically, retention passage 180 provides structural features whichan infusion line can be looped against or around. The retention passage180, accordingly, provides resistance from an infusion line beingunintentionally pulled away from the syringe pump 100. Such pulling ofthe infusion line will meet resistance from the retention passage 180,rather than at the point where the infusion line is connected to asyringe located within the syringe receptacle 116.

As illustrated in, for example, FIGS. 1 and 3 , syringe plunger driverassembly 114 is substantially located at an end of the syringereceptacle 116. Plunger driver assembly 114 includes a plunger driver182, bumper 184, trigger 186, and flipper 188, among other components.The plunger driver assembly 114 is responsible for controlling deliveryof a prescribed amount or dose of an infusate from a syringe in the pump100 to a patient by mechanically depressing a plunger in the syringe todeliver the infusate at a controlled rate through an infusion linefluidly connected to the syringe. More specifically, a motor 190 rotatesa leadscrew which, in turn, causes the plunger driver 182 that isoperatively coupled to the leadscrew to move in a direction of thesyringe receptacle 116. This movement then pushes the plunger within abarrel of the syringe located within the receptacle 116. Pushing thesyringe plunger forward acts to force a dose of infusate in the syringeoutwardly from the syringe, into an infusion line, and ultimately to apatient.

In the illustrated example of pump 100, bumper 184 of the plunger driverassembly 114 can be a generally rounded, end portion of plunger driverassembly 114 opposite the syringe receptacle 116. The bumper 184 isgenerally larger in diameter than the central portion of the plungerdriver 182 and is made of a durable material that is relatively easy andergonomic to grip. The bumper 184 is made for aiding in one-handedmanipulation of the plunger driver assembly 114. Additionally, the“padded” construction of the bumper 184 provides some resistance tounintended impacts. Accordingly, based on its size and material, theplunger driver 182 is designed to help absorb any unintentional impactson the plunger driver assembly 114, in an event of, for example, adropped or mishandled syringe pump 100.

The trigger 186 is positioned at the back side of the plunger driverassembly 114. Trigger 186 is spring-loaded and acts to unlock theplunger driver assembly 114 from a locked state, such that the plungerdriver assembly 114 can then relatively freely slide laterally when thetrigger 186 is depressed. As depicted in, for example, FIG. 3 , flipper188 is located between the syringe receptacle 116 and the main plungerdriver section 182 of the plunger driver assembly 114. The flipper 188is generally a curved arm which extends over a distal thumb-pressportion of a plunger in a syringe to help to removably secure thesyringe in pump 100. Also in the proximity of the plunger driverassembly 114 is a barrel clamp lever 192 located under the keypad 120 ofthe user interface 110. Barrel clamp lever 192 may be manipulated tofurther engage or disengage retaining members from around the barrel ofa syringe being removably secured in pump 100.

In general, the bumper 184, trigger 186, flipper 188, and barrel clamplever 192 are used in loading and unloading operations of syringes intoor out of the syringe receptacle 116. In the case of loading operationsof syringes into the syringe pump 100, an initial step is to extend theplunger driver assembly 114 outwardly, away from the syringe receptacle116. In order to accomplish this, a user can manipulate and engage thebumper 184 on the end of the plunger driver assembly 114 using the palmof his/her hand and depress the trigger 186 on the rear side of theplunger driver assembly 114 with his/her fingers of that same hand.Depressing the trigger 188 releases the plunger driver 182 from itslocked position and allows the plunger driver 182 to slide outwardly andaway from receptacle 116. Accordingly, the plunger driver 182 isinitially slid to a desired distance appropriate for the syringe barrelof the syringe. Next, the syringe is placed into the syringe receptacle116 such that the end of the syringe barrel abuts the interior surfaceof the plunger driver assembly 114 location, opposite the bumper 184. Aninfusion line connected to the syringe is threaded through the retentionpassage 180 at the end of the syringe receptacle 116 located oppositethe plunger driver assembly 114. The flipper 188 rotates to descend overthe thumb-press of the plunger in the syringe barrel and the barrelclamp lever 192 is manipulated so that the syringe barrel is furtherheld in place. The user can then manipulate the user interface 110 tocontrol the syringe pump 100 in the desired manner.

FIG. 7 depicts an example of a general system diagram of the syringepump 100, including some components that are partially or fully obscuredby the housing 112. Referring also to FIGS. 1-6 , the system diagram ofFIG. 7 shows a diagram of a syringe pump 100, including user interface110, controller 194, motor 190, drive components (drivetrain) 196, powerreceptacle 166, battery 174, electrical circuitry 198, Ethernetconnector 168, USB input port 170, speakers 128, and plunger driver headsensors 199.

As discussed above, the user interface 110 serves as a source of datainput for the syringe pump 110 from, for example, a medical practitioneror pump programmer. Although not specifically illustrated in FIG. 7 , itis to be appreciated and understood that user interface 110 may includea touchscreen display 118, keypad 120 or a combination of these or otheruser interface technologies.

In this example, controller 194 is connected to the user interface andis responsible for ensuring that the pump 100 is controlled in thedesired manner. Controller 194 is located in the housing 212 andcontrols operation of the motor 190 and drive components 196. Controller194 may include one or more processors. Controller 194 may furtherinclude memory in some embodiments.

Motor 190 is connected to the controller 194 and syringe pump componentsgenerally. Motor 190 may be included in the plunger driver assembly 114in some embodiments. Motor 190 is the primary means for directing thedrivetrain 196 (or drive components) to effect movement of the plungerdriver assembly 114. Drivetrain 196 may be a set of drive componentsthat are at least partially located in the housing 112 which areresponsible for mechanically directing infusion of fluid from a syringethat has been operatively installed in pump 100.

The syringe pump system further includes either line power via a cordconnected to the power receptacle 166 or via a connector in a rack thatconnects to the power receptacle 166. Battery 174 provides anotheralternate source of power to the infusion pump 100. In an embodiment,battery 174 is fully enclosed in the housing 112 beneath the rearbattery panel 164.

Various electrical components and electrical circuitry 198 are locatedwithin the housing 112 that are required for relaying or carrying outcommands to the controller 194 or within the system. Various outsidedevices may be connected to the syringe pump 100 as well through inputs,such as an Ethernet connector 168 or USB input port 170.

The speakers 128 are equipped to provide a full range of audio outputincluding commands, alerts, and informative communications. Plungerdriver head sensors 199 and other sensors are part of the system aswell. Plunger driver sensors 199 can, for example, make variousmeasurements for tasks such as characterizing syringes, detectingocclusions, and determining plunger position. Controller 194 utilizesinformation gained from these sensors 199 and other components to assistin communications and decision-making in set-up and operation of pump100.

LVP

Referring to FIGS. 8-13 , an example of a LVP 200 is shown. LVP 200generally includes a user interface 210, housing 212, and assemblyreceptacle 213. Various other features of the LVP 200, including somethat are internal or partially or fully obscured by the housing 212,will be later described with reference to the LVP system diagram of FIG.14 .

In general, significant portions of LVP 200 in FIGS. 8-14 and thesyringe pump 100 described above and in FIGS. 1-7 are similar oridentical. Accordingly, discussions of components having referencenumerals in the “100's” in FIGS. 1-7 should generally be deemed tocorrespond to and apply to the similar components having correspondingreference numerals in the “200's” in FIGS. 8-14 , unless otherwisedistinguished in the following discussion (for example, the discussionof keypad 120 in FIG. 1 applies to keypad 220 in FIG. 8 as well).

As seen in FIG. 8 , user interface 210 generally includes a displayscreen 218 and a keypad 220. User interface 210, display screen 218 andkeypad 220 respectively correspond to user interface 110, display screen118 and keypad 120. A variety of configurations for touchscreen andmechanical buttons are contemplated.

The housing 212 corresponds to housing 112 and generally forms aprotective shell surrounding the internal components of the LVP 200. Insome embodiments, the user interface 210 may be considered part of thehousing 212. The housing 212 can be characterized as generallycomprising a front housing assembly 222 and a rear housing assembly 224.

Front housing assembly 222 generally surrounds the LCD display screen218, keypad 220 and other components in the proximity of the userinterface 210. Front housing assembly 222 is largely the same as thefront housing assembly 122 of the syringe pump 100, however, the shapeof the front housing assembly 222 around the assembly receptacle 213 anduser interface 210 is shaped differently so that the features of theassembly receptacle 213 are appropriately accommodated.

Rear housing assembly 224 is generally consistent with rear housingassembly 124. Features on the rear housing assembly 224 include a handle232, central recess 234, and a generally U-shaped retaining feature 236defined in the top portion 230 of the housing 212. These features areanalogous to those discussed with respect to the syringe pump 100 aswell. The generally U-shaped upper lip portion 238 surrounding centralrecess 234 and receiving grooves 240 extend inwardly from rear face 242.This arrangement provides features for receiving a projection of anotherpump and gripping the U-shaped retaining features 236 as a handle 232.

As in the syringe pump 100, the handle 232 of the LVP 200 is integratedwith housing 212 and is part of the generally U-shaped retaining feature236. Similarly, generally U-shaped projection 252 is located on thebottom portion 254 of the housing 212 and is analogous to the generallyU-shaped projection of the syringe pump 100. As in the configuration ofsyringe pump 100, U-shaped projection 252 is comprised of a forwardportion 256 and rearward portions 258. The rearward portions 258 includea flange 260 and outwardly extending lip 262 which are sized to engagewith retaining grooves 240 of another pump. Accordingly, LVPs 200 andsyringe pumps 100 can be readily stacked and coupled with one another.

With particular reference to FIG. 9 , features that can be seen on therear face 224, sides 226, and bottom portion 254 of the housing 212include: a battery door cover 264, power receptacle 266, Ethernetconnector 268, USB port 270, and mounting feet 272. Each of thesecomponents correspond to analogous parts of syringe pump 100.

Also shown in FIGS. 8-13 , is an assembly receptacle 213. Assemblyreceptacle 213 includes an elongate cavity extending across the front ofthe LVP 200. Assembly receptacle 213 is located directly below thedisplay screen 218 of the user interface 210. Assembly receptacle 213contains passages 251 out each end as well as a central passage throughwhich an infusion line for carrying out patient infusion can extendthrough and be acted on. Further, assembly receptacle 213 includesfeatures permitting a tubing frame assembly of the patient infusion lineto be removably mounted and acted on by fingers of a peristaltic pumpingmechanism.

The interior features of the assembly receptacle 213 are largelyobstructed from view in FIGS. 8-13 by a hinged door 253. Door 253further contains a centrally located latch lever 255 for securing thedoor 253 in the closed position depicted. When the LVP 200 is in use,the door 253 is first placed in an open orientation. A tubing frameassembly coupled to the infusion line is received by the assemblyreceptacle 213. This loading of the tubing frame assembly can be donevia one-handed motion. Next, the door 253 can be rotated closed abouthinges 257 (as illustrated in, for example, FIG. 13 ) at the bottomfront edge 259 of the LVP 200. Door latch lever 255 can then be movedfrom an unlatched position to a latched position as shown in FIGS. 8-13. For purposes of this description, the operational details of the LVPcomponents in the assembly receptacle 213 are not specificallydiscussed.

As depicted in, for example, FIG. 10 , assembly receptacle 213 includesinfusion line retention passages 251 at both ends. The retentionpassages 251 (or tube guides) provide a narrow segments in which aninfusion line can pass. At any suitable time, which may be before orafter door 253 is closed, upstream and downstream tubing (notillustrated in FIGS. 8-13 ) can be manually pressed into retentionpassages 251.

Various assemblies and methods for infusion system administration setssuch as, for example, an aforementioned tubing frame assembly that canbe removably secured in receptacle 213, are discussed in PCT App No.PCT/US2017/037929 of Adams et al., titled “Assemblies and Methods forInfusion Pump System Administration Sets”, and published as WO2017/218927 A1, which is hereby incorporated by reference.

FIG. 14 depicts an example of a general system diagram of the LVP 200,including some components that are partially or fully obscured by thehousing 212. The system diagram shows a diagram of a LVP 200, includinguser interface 210, controller 294, motor 290, drive components 296,power receptacle 266, battery 274, electrical circuitry 298, Ethernetconnector 268, USB input port 270, speakers 228, and assembly receptaclesensors 299.

As discussed above, the user interface 210 serves as a source of datainput for the syringe LVP 200 from, for example, a medical clinician orpump programmer. Although not specifically illustrated in FIG. 14 , itis to be appreciated and understood that user interface 210 may includea touchscreen display 218, keypad 220 or a combination of these or otheruser interface technologies.

In this example, controller 294 is connected to the user interface andis responsible for ensuring that the pump is controlled in the desiredmanner. Controller 294 may include one or more processors. Controller294 may further include memory in some embodiments.

Motor 290 is connected to the controller and LVP components generally.Motor 290 can be a stepper motor in some embodiments. In this example,motor 290 is the primary means for directing the drive components 296 toeffect movement of the fingers in the assembly receptacle 213 (asillustrated in, for example, FIG. 8 ) against the tubing.

The example of the LVP system in FIG. 14 further includes either linepower, via a cord connected to the power receptacle 266 or, via aconnection member in a rack that connects to the power receptacle.Battery 274 is another alternate source of power to the LVP 200. Thebattery 274 can be fully enclosed in the housing 212 beneath the rearbattery door cover 264 (as depicted in FIG. 9 , for example).

Referring again to FIG. 14 , various electrical components andelectrical circuitry 298 are located within the housing 212 for relayingor carrying out commands to the controller 294 or within the system.Various outside devices may be connected to the LVP 200 as well throughinputs, such as an Ethernet connector 268 or USB port 270.

The speakers 228 are equipped to provide a full range of audio outputincluding commands, alerts, and informative communications. Assemblyreceptacle sensors 299 and other sensors can be part of the system aswell. Assembly receptacle sensors 299, for example, can make variousmeasurements for tasks such as sensing information about the particulartubing frame assembly. This can include sensing the route of infusionfor which a particular tubing frame assembly is used. Sensors can beoptical sensors, RFID readers, etc. Controller 294 can utilizeinformation gained from these sensors 299 and other components to assistin communications and decision-making in set-up and operation of pump100.

As noted above, syringe pump 100 and LVP 200 make use of a plurality ofindividual FRUs that enable pump components to be readily upgraded orreplaced. FRU components provide ease of pump manufacture as well assimplified maintenance and replacement. Various FRU configurationscontemplated herein can be interchangeable and common to both types ofinfusion pumps discussed. In general, FRUs can be categorized into threegroups: wear components (components that will need to be replaced due tobreakage or end-of-life, etc.); faster moving technology(communications, WiFi, Bluetooth®, USB, the display); and functionalityupgrades (syringe security, PCA, TCI, etc.). FRUs can be interchangedbetween categories at times as well by virtue of these being moduleswith interfaces. For example, to improve the performance of a wearcomponent, a user might upgrade the functionality. E.g., a pumpingmechanism that does not meet breakage or wear component requirementscould be “upgraded” by higher performance or added feature FRUs—onesthat have the desired capabilities to essentially replace the previouswear component. In a pump, a higher-performance FRU can be recognized bythe pump and the pump's operating parameters can be adjustedautomatically to be compatible with the newly installed FRU.Additionally, the pump would have knowledge of its configuration andtherefore it would essentially report back its own configuration forlogging into, e.g., a DMR (Device Master Record).

In one example, both syringe pump 100 and LVP 200 have a common FRUcomprising the rear portion of the pumps. This common FRU includessignificant portions of the housing and rear components for both typesof infusion pumps discussed. This component is shown as FRU 101 in FIG.15 . and can be understood from corresponding reference numerals andparts of FIGS. 1-14 as well. Specifically, FRU 101 largely includes rearhousing assembly 124 or 224 for an infusion pump. The rear housing 124or 224 includes a top portion 130 or 230 and part of bottom portion 154or 254. The top portion 130 or 230 has an integrally formed handlestructure 132 or 232 and a set of receiving grooves 140 or 240. Thebottom portion 154 or 254 has a projection 152 or 252 for releasablecoupling with receiving grooves (such as 140 or 240) in another rearhousing. The rear housing 124 or 224 can include a power receptacle 166or 266 and an Ethernet connector 168 or 268. The rear housing 124 or 224interchangeably couples with a set of infusion pump system components(such as a plunger driver assembly 114 and syringe receptacle 116 or LVPmotor and drive components and assembly receptacle 213), a controlsystem (such as controller 194 or 294), and a display of either a LVP ora syringe pump (such as display screen 118 or 218).

In some embodiments, FRUs can include components or groups of componentsof the pump. Examples of such FRUs can include: a rear housing assembly;an LVP front housing with motor, pump, display and keypad; a syringefront housing with display and keypad; a battery pack with gas gauge; apower supply; wireless components; a PCB BOARD assembly; a LVP door; asyringe drive; and a syringe plunger head.

In some embodiments, FRUs can include battery pack modules (additional,supplemental, or standby). Similarly, in some embodiments, FRU's caninclude battery charging or power modules (possibly incorporating orinterfacing with portable solar, wind, or mechanical crank-typegenerators). Interfaces to off-the-shelf batteries for military use canbe provided in some embodiments. In certain cases, a battery charging orpower module can interface with one or more pumps that are “connected”.For example, a pump and a headless pump, in a stack could all interfacewith a battery charging or power module.

In some embodiments, FRUs can include alarm modules (both visual and/oraudible). Specifically an alarm module can interface with one or morepumps that are “connected”. For example, a pump and a headless pump, ina stack could all interface with an alarm module.

In some embodiments, FRUs can include: PCA modules; syringe securitydevices (such as a lockbox); a communications module; or a userauthentication module (such as one using biometric inputs, offingerprints, voice, facial recognition, etc.) that can unlock an entireconnected stack.

In some embodiments, FRUs of power and communication relate toalternatives to or proxies for a rack. In some embodiments, FRUs havingBluetooth® or Wifi are contemplated. In some embodiments, the FRUs canbe in a daisy chain of communication (wired or wireless) and/or power.In some cases, FRUs include power selector or adapter modules. Forexample, modules for adaptation to local (unique) power sources or powersources that are commonly used for or in other devices (AC/DC power). Invarious embodiments, FRUs can be locked.

In other contemplated embodiments, the pumps themselves can be FRUs. Forexample, this can be the case in a collective pumping arrangementcomprising a syringe pump, an LVP and a headless syringe. In someembodiments, an FRU can copy the programming of a device that hasfailed. See PCT App. No. PCT/US2017/042633 of Diez et al., titled“Cloning Medical Device Configurations”, and published as WO 2018/022355A1, which is hereby incorporated by reference.

Referring to FIGS. 16A and 16B, infusion pump arrangements are shownwhich depict the racking and stacking capabilities of the pumps.Specifically, FIG. 16A depicts a pole mounted arrangement 300 in which aplurality of syringe pumps 100 are mounted on a movable rack 310. Rack310 is designed to hold up to eight infusion pumps 100, as depicted, insome embodiments. Rack 310 has a wide wheeled base with legs 320 whichaids in preventing the rack from tipping. Further, an IV pole 330, isattached via arms 340 extending from the side of the rack 310. The IVpole 330 is located above a leg 320 of the rack 310 so that the weightof any bag(s) of mounted fluid or infusate, such as an IV bag, will besupported and will not cause instability to the rack 310. In someembodiments, rack 310 can be further advantageous as it can provide anAC power supply, space management, and a consolidated Ethernetconnection.

Rack 310 permits the individual installation and removal of infusionpumps, such as syringe pumps 100. This individualized mountingcapability means that a suitable syringe pump 100 or other suitableinfusion pump can be readily installed or removed from a group of suchpumps. This flexibility is particularly advantageous for troubleshootingand reconfiguring groups of infusion pumps.

The vertically grouped arrangement of the racked arrangement 300 in FIG.16A can be analogous to the stacked arrangement 400 of FIG. 16B as well.Specifically, in this example of FIG. 16B, syringe pumps 100 can be seenstacked directly above or below each other, vertically. This type ofstacking may utilize a pole mount, in some embodiments, for example.When the top syringe pump 100 is secured in place, for example, asubsequent syringe pump 100 can be secured below it by attachmentfeatures integrated into the syringe pump housing 112 of both pumps.Specifically, and as aforedescribed, the generally U-shaped projection152 on the bottom of the top syringe pump 100 permits the receivinggrooves 140 of the generally U-shaped retaining feature 136 of the belowsyringe pump 100 to be slid over the outwardly extending lip 162. TheU-shaped retaining feature 136 is slid until the forward portion 156 ofthe U-shaped projection 152 abuts underneath the upper lip portion 138of the below syringe pump 100. A feature of this stacked arrangement ofsyringe pumps 100 is that each user interface display screen 118, aswell as corresponding syringes 102, can be readily viewed at the sametime. This permits a medical practitioner the ability to quickly see thestatus of all the syringe pumps at one glance, even if done from acrossa room.

Although FIGS. 16A and 16B show syringe pumps 100 in racked and stackedarrangements, other types of infusion pumps should be understood to becapable of being racked and stacked in this manner, as well, such asLVPs 200. Accordingly, racks and stacks of either all syringe pumps 100,all LVPs 200, or a mix of different kinds of pumps racked or stackedtogether are possible.

Referring to FIG. 17 , a perspective view is shown of an infusion pumpconfiguration 500 in which an external backup battery pack 501 isattached to a syringe pump 100. An external backup battery pack 501 maybe used in cases where access to AC power is limited. For example, inmore remote regions or in transport vehicles, having a group of batterypower supplies can provide the flexibility needed to run infusion pumpsin nearly any location for extended periods of time. The external backupbattery pack 501 contemplated can have a cord which plugs into the powerreceptacle 166 in the back of the housing 112 to supply power to thesyringe pump 100. The external backup battery pack 501 can also have agenerally U-shaped projection of the battery pack 501 on its bottomsurface similar to the generally U-shaped projections 152 and 252 on thebottom of the infusion pumps 100 and 200 described herein. Accordingly,this generally U-shaped projection is able to mate with the generallyU-shaped retaining feature 136 or 236 on the top of the pump 100 or 200.This arrangement provides a secure and durable coupling for the pump 100or 200 and its power supply. Moreover, once external backup battery pack501 runs low on power, another similar unit can simply replace it andlikewise attach to the top portion of the syringe pump 100.

FIG. 18 depicts an embodiment of an infusion pump configuration 600,including a set of infusion pumps including a LVP 200 coupled to a setof stacked, “headless” LVPs 611. In general, LVP 200 depicts an LVPsimilar to those described in FIGS. 8-14 . This LVP 200 is shown in astacked arrangement with other “headless” LVPs 611. These LVPs 611 are“headless” in the sense that they do not contain the user interface 210of LVP 200 and are much more compact in size. These headless LVPs 611are made possible when a stacked arrangement (or racked, if on a rack)is constructed and operatively coupled in communication which can relyon one user interface 210 to control pumping operations of a stacked or(racked) set of infusion pumps. Constructing such “headless” LVPswithout including relatively more expensive user interface components oneach pump can provide a significant cost savings to pump manufacturing.In an embodiment, “headless” pumps can communicate with each other viaBluetooth® or other wireless communication. “Headless” pumps can alsobe, additionally or alternatively, wired to each other and maycommunicate via USB or Ethernet ports, for example.

Headless LVPs 611 may each include a generally U-shaped retainingfeature 236 on their top surfaces and a generally U-shaped projection252 on the bottom surface similar to the ones described for the LVPs200. Accordingly the pumps can be readily coupled with so-called“tongue-and-groove” arrangement similar to the arrangements 300 and 400in FIGS. 16A and 16B. Further, “headless” pumps are not limited to LVPs.Syringe pumps 100 can also be provided as “headless” infusion pumps inwhich no user interface is contained on certain syringe pumps 100 in apump stack or rack.

Other ease of use features are also contemplated by this disclosure. Forexample, in some embodiments, all pump components with which a user isintended to interface are specially color coded. In the case of theexample of syringe pump 100 herein, each of the areas for userinteraction are visually color-coded blue. Accordingly, the bumper 184,trigger 186, keypad 120, barrel clamp lever 192, USB port 170, Ethernetconnector 168, catch 148 and pump latch button 150 would be coloredblue. In the case of the LVP 200, the latch lever 255, keypad 220, USBport 270, Ethernet connector 268, catch 248 and pump latch button 250would be colored blue.

Throughout this disclosure and figures, generally U-shaped retainingfeature 136, generally U-shaped retaining feature 236, generallyU-shaped projection 152, generally U-shaped projection 252, and otherfeatures described as “generally U-shaped” should be interpreted in alargely non-limiting manner and can also be alternatively and/orinterchangeably referred to understood as simply being “U-shaped”.Although the components referenced are largely understood based on theirdepiction from a top or bottom perspective, the “U-shaped” and“generally U-shaped” terminology should be interpreted in a largelynon-limiting way. For example, the description can be understood toinclude one continuous largely semicircular shape or a shape having abase with two side members extending therefrom. The term “U-shape” caninclude base and side components having rounded or squaredintersections. The side components can be disposed in parallel,converging or diverging orientations. In some embodiments, a “generallyU-shaped” component is broad enough to include side members that meet ata single base location to form a “V”. Other configurations are possibleas well. Accordingly, corresponding claim terms should be interpreted ina corresponding, broadly construed manner.

Various embodiments of systems, devices, and methods have been describedherein. These embodiments are given only by way of example and are notintended to limit the scope of the claimed subject matter. It should beappreciated, moreover, that the various features of the embodiments thathave been described may be combined in various ways to produce numerousadditional embodiments. Moreover, while various materials, dimensions,shapes, configurations and locations, etc. have been described for usewith disclosed embodiments, others besides those disclosed may beutilized without exceeding the scope of the claimed subject matter.

Persons of ordinary skill in the relevant arts will recognize that thesubject matter hereof may comprise fewer features than illustrated inany individual embodiment described above. The embodiments describedherein are not meant to be an exhaustive presentation of the ways inwhich the various features of the subject matter hereof may be combined.Accordingly, the embodiments are not mutually exclusive combinations offeatures; rather, the various embodiments can comprise a combination ofdifferent individual features selected from different individualembodiments, as understood by persons of ordinary skill in the art.Moreover, elements described with respect to one embodiment can beimplemented in other embodiments even when not described in suchembodiments unless otherwise noted.

Although a dependent claim may refer in the claims to a specificcombination with one or more other claims, other embodiments can alsoinclude a combination of the dependent claim with the subject matter ofeach other dependent claim or a combination of one or more features withother dependent or independent claims. Such combinations are proposedherein unless it is stated that a specific combination is not intended.

Any incorporation by reference of documents above is limited such thatno subject matter is incorporated that is contrary to the explicitdisclosure herein. Any incorporation by reference of documents above isfurther limited such that no claims included in the documents areincorporated by reference herein. Any incorporation by reference ofdocuments above is yet further limited such that any definitionsprovided in the documents are not incorporated by reference hereinunless expressly included herein.

For purposes of interpreting the claims, it is expressly intended thatthe provisions of 35 U.S.C. § 112(f) are not to be invoked unless thespecific terms “means for” or “step for” are recited in a claim.

1. An infusion pump, comprising: a housing enabling selective stackedattachment with other infusion pumps, including: a top portion with ahandle integrated into an outer surface that partially defines agenerally U-shaped retaining feature; a bottom portion with a generallyU-shaped projection contoured to selectively mate with a retainingfeature of another infusion pump; a user interface providing a frontside to the housing that receives commands regarding infusion pumpoperation; a motor and a set of drive components, at least partiallylocated within the housing, that mechanically direct infusion of aninfusate; and a controller located within the housing that controlsoperation of the motor and the set of drive components.